Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

September 2, 2009 updated by: The Hong Kong Polytechnic University
The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shatin, Hong Kong, China
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis with COPD

Exclusion Criteria:

  • allergic to gel
  • unable to perform spirometry
  • unable to communicate
  • no history of infection or exacerbation of respiratory symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but without electrical stimulation
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but applied onto non acupuncture point
Placebo Comparator: Group 2
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but without electrical stimulation
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but applied onto non acupuncture point
Sham Comparator: Group 3
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Transcutaneous electrical nerve stimulation applied onto acupuncture point
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but without electrical stimulation
Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
Similar to Group 1 but applied onto non acupuncture point

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
Time Frame: measured before and after the 4-week program
measured before and after the 4-week program

Secondary Outcome Measures

Outcome Measure
Time Frame
beta endorphin, St George Respiratory Questionnaire (SGRQ)
Time Frame: measured before and after the 4-week program
measured before and after the 4-week program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2009

Last Update Submitted That Met QC Criteria

September 2, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2007.158-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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